Developing an Automated Robotic Factory for Novel Stem Cell Therapy Production

Avoidance of total knee arthroplasty in early osteoarthritis of the knee with intra-articular implantation of autologous activated peripheral blood stem cells versus hyaluronic acid: A randomized controlled trial with differential effects of growth factor addition

“…In nonhematological regenerative uses, we believe that an autologous origin of stem cells must be the only choice as the use of allogeneic sources is invariably tainted with an inherent risk of rejection and unease for potentially life-threatening complications [26,27], the need for future immunosuppression [27], and the concern for a diminished effect due to immunovigilance [26][27][28] as well as worsening of inflammation in OA [27] or malignancies [29]. Moreover, allogeneic sources are usually preferred for obvious commercial and patentrelated reasons and not due to ease of procurement or cost [30]. Isolated MSC of any source must invariably be expanded, and these manipulated allogeneic cells are prone to cytogenetic issues and infection/contamination risks as no uniform rules have been adopted [29][30][31].…”

“…Moreover, allogeneic sources are usually preferred for obvious commercial and patentrelated reasons and not due to ease of procurement or cost [30]. Isolated MSC of any source must invariably be expanded, and these manipulated allogeneic cells are prone to cytogenetic issues and infection/contamination risks as no uniform rules have been adopted [29][30][31]. We do yet not know which cell fraction(s) or specific cells are the most appropriate in regenerating cartilage.…”

Cell Therapy-Processing Economics: Small-Scale Microfactories as a Stepping Stone Toward Large-Scale Macrofactories

“…The benefit of choosing a universal donor-type therapeutic model rather than a patient-specific one is clear: one lot to one patient is increasingly challenging to manufacture and with this complexity comes significantly increased costs. Scalable expansion technologies with multiple, isolated product streams are the key to realizing the promise of personalized autologous therapies [26], but these technologies are not yet ready for commercial success [11]. The case study presented here examines both manual processes and automated processes.…”

Cell and gene therapy manufacturing: the necessity for a cost-based development approach

“…Knowledge of how the dominant features of manufacturing may alter the functionality of biological products is critical to any success with decentralization and will facilitate automated manufacture [5,9]. It is anticipated that the adoption of automated manufacture will decrease variability in the quality of manufactured cell products, resulting in more consistent clinical outcomes that exhibit both reproducibility and, importantly, dose-responsiveness.…”

“…However, for certain cell and gene based therapies, in particular autologous products, it is likely we will witness a reversion to a redistributed, decentralized manufacturing approach. This is coupled with recent advances in technology that have permitted reproducible, repeatable and reliable manufacture of highly specialist products at a small scale [1][2][3][4][5]. Equally important, however, are the advances in real-time monitoring and quality management systems (QMSs) which ensure that these small-scale manufacturing platforms are continuously monitored even in the absence of skilled human operators.…”